https://s3.amazonaws.com/omeka-net/13418/archive/files/e5c316d038d2bf4402c6964f6ea3d72d.pdf?AWSAccessKeyId=AKIAI3ATG3OSQLO5HGKA&Expires=1592438400&Signature=tfrTDw%2FB%2FsaBLrHa0gEXwL6%2BRrg%3Db572ea2f221a0f4a497b0a1577eb6a28PDF TextTextKeeping Up With Sterile Preparations & USP <797>
Patricia Gerrin CPhT CSPT, Denise Arena Raphe Clinical Pharmacist Supervisor, Julie F Lanza CPhT CSPT
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Introduction/Problem
The Interventions
USP <797> requires the skill of personnel that aseptically prepare CSPs (Compounded
Sterile preparations) be evaluated using sterile fluid bacterial culture media fill
verification. Media fill test represent the most challenging or stressful conditions
encountered by personnel being evaluated when they prepare all risk level CSPs.
 Train multiple staff to perform media fill verification in order to complete testing in more timely
manner
 Working with pharmacy supervisors and the scheduler(s) for both Pharmacist & Technicians as
well as the Sterile Products team to develop a timeline of events that wouldn’t effect the day
today operations of the Pharmacy Department.
 Creating a spreadsheet of materials. times, places, staff & verifications processes that need to
happen for the total number of staff to be tested
 Data (including time it takes for each test) in monitored throughout the time frame to maintain
the timeline & improve processes for next testing session.
Media fill test verification are done annually or biannually depending on risk level.
At BIDMC, in order to comply with this regulation – we were faced with the challenge of
coordinating media fill test verification of all risk levels for approximately 160
employees for a total of 400 tests (knowing these numbers would increase each
year with staffing levels).
Aim/Goal
 Aim: trying to coordinate 400 different tests in an organized fashion while not disrupting
existing work flow or interrupting the attention to patient care that our employees are
providing.
 Goal: Develop a system that allows us to compete media fill verification for all employees
within a short time frame.
The Team




Denise Arena – RPh Clinical Pharmacist Supervisor
Patricia Gerrin – CPhT CSPT – Lead Technician Sterile Products
Bzunesh Abrha CPhT – Lead Technician Scheduling & Training Coordination
Julie Lanza CPhT CSPT – Pharmacy Compliance Specialist
Results/Progress to Date
Media Fill Verification 2017
June 9th thru August 8th
210
82
LowMedium
Hazardous
140
Media Fill Verification 2018
August 2nd thru Sept 13th
211
170
81
82
152
High Risk
Finger Tip
Low Medium
Hazardous
High Risk
Finger Tip
2017 time lapse of testing was 60 days. Upon implementation of new processes,
2018 testing was decreased to 42 days with an increase number of staff tested.
Through new processes, we were able to decrease testing by 18 days.
For more information, contact:
Patricia Gerrin CPhT CSPT (pgerrin@bidmc.Harvard.edu)
�Keeping Up With Sterile Preparations & USP <797>
Patricia Gerrin CPhT CSPT, Denise Arena Raphe Clinical Pharmacist Supervisor, Julie Lanza CPhT CSPT
More Results/Progress to Date
Both USP <797> & the MA Board of Registration in Pharmacy are due to release
new standards for media fill test verification in 2019. We have already begun to
develop ideas by which these proposed changes will affect our current testing
processes.
Test
Old Regulation
New <USP>
regulations
New board of
Pharmacy
Regulations
Low/Medium
Annually
Biannually
Biannually
High Risk
Biannually
Biannually
Quarterly
Chemo/Hazardous Annually
Biannually
Biannually
Finger-Tip
Biannually
Biannually
Annually
Based on the changes to regulations proposed above, we will be tasked with
having to revise our testing processes & invest exponentially more to purchase
testing supplies
In addition to the Media Fill Verification Testing, all BIDMC Pharmacy employees who
compound Sterile Products are required to complete & pass three didactic exams as well as
attend an Annual Lecture on the updates/changes of <USP> 797. This allows us to maintain
competency & compliance in regards to the laws/regulations.
In addition to USP & MA Board of Pharmacy regulations, The Pharmacy
Technician Certification Board (PTCB) has launched an optional certification for
Advanced Sterile Products (CSPT) technicians in 2018.
BIDMC has six technicians who have taken this certification exam which has
allowed us the flexibility and ability to have more advanced trained sterile products
employees performing these verification tests to ensure compliance with national
standards.
Lessons Learned
 Pertaining to the world of Sterile Products and USP <797>; lessons are
continually evolving as the regulations and parameters set around
compounding and patient safety are constantly changing.
 Our lessons involve continuous education around the best way to maintain our
quality assurance & performance standards here at BIDMC.
Next Steps
 Maintain monitoring of our current processes & use metrics to implement measures that
will improve processes.
 Keeping up with all the changing regulations that are published by the USP
 Promote current and future pharmacy technician staff to sit for CSPT exam allowing for a
more comprehensive group of sterile products employees
For more information, contact:
Patricia Gerrin CPhT CSPT (pgerrin@bidmc.harvard,edu)
�Dublin CoreThe Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.TitleA name given to the resourceSilverman SymposiumDescriptionAn account of the resourceEach year the Silverman Symposium poster session offers BIDMC staff and affiliates the opportunity to share experiences and learn about efforts to improve Quality and Safety.DateA point or period of time associated with an event in the lifecycle of the resource2018Silverman PosterPrimary ContactIf you would like more information about this project, contact this person. Make email address clickable.Patricia Gerrin (<a href="mailto:pgerrin@bidmc.harvard.edu" target="_blank" rel="noreferrer noopener">pgerrin@bidmc.harvard.edu</a>)DepartmentAny departments listed on the poster or identified in the spreadsheet.PharmacyBIDMC LocationThe BIDMC location where the poster team resides if identified in spreadsheet. If not identified, choose BIDMC.BIDMCProject TeamDenise Arena
Patricia Gerrin
Bzunesh Abrha
Julie Lanza Dublin CoreThe Dublin Core metadata element set is common to all Omeka records, including items, files, and collections. For more information see, http://dublincore.org/documents/dces/.TitleA name given to the resourceKeeping up with Sterile Preparation & USP <797>DateA point or period of time associated with an event in the lifecycle of the resource2019FormatThe file format, physical medium, or dimensions of the resourcepdfComplianceEffectivenessEfficiency